Real-world study shows subcutaneous vedolizumab effective for maintenance in IBD

Switching from intravenous to subcutaneous vedolizumab for maintenance treatment of inflammatory bowel diseases appears to be effective, according to a study providing real-world data.

Subcutaneous treatment could reduce direct health care costs because no infusion equipment is necessary, as well as societal costs because patients don’t need to take time off work or travel to infusion locations, wrote the researchers, led by Adriaan Volkers, MD, a doctoral candidate in gastroenterology and hepatology at the Amsterdam Gastroenterology Endocrinology Metabolism Research Institute at the University of Amsterdam in The Netherlands.

“The option of a SC formulation of VDZ [vedolizumab] offers patients a choice regarding the route of administration,” they wrote. The study was published in Alimentary Pharmacology and Therapeutics.

Dr. Volkers and colleagues assessed the effectiveness, safety, drug discontinuation, and pharmacokinetics of a switch from intravenous to subcutaneous maintenance vedolizumab in a prospective real-world cohort of patients from two separate studies in The Netherlands between July 2020 and November 2021.

The cohort comprised 135 adults who had greater than 4 months of IV vedolizumab: 82 patients with Crohn’s disease and 53 with ulcerative colitis. Prospective follow-up took place during scheduled outpatient clinic visits at weeks 12 and 24 after switching administration. Patients received 108 mg of subcutaneous vedolizumab once every 2 weeks.

Overall, 16 patients (11.9%) discontinued subcutaneous administration, including 11 patients (13.4%) with Crohn’s disease who stopped after a median of 18 weeks, as well as 5 patients (9.4%) with ulcerative colitis who stopped after a median of 6 weeks. Four patients, who all had Crohn’s disease, discontinued vedolizumab and switched to a different treatment because of loss of response. Nine patients switched back to IV administration because of adverse events, and three switched back because of fear of needles.

In total, there were 59 adverse events and 13 infections that were possibly or probably related to subcutaneous injection among 42 patients. The most common adverse events that were probably related were injection site reactions such as pain or swelling, reported among 15 patients, and headaches, reported among 6 patients.

At the initiation of therapy, 57 of 81 Crohn’s disease patients (70.4%) were in corticosteroid-free clinical remission and 53 of 80 (66.3%) were in biochemical remission, which was defined as C-reactive protein levels of 5 mg/L or less and fecal calprotectin levels of 250 mcg/g or less. For ulcerative colitis patients, 35 of 49 (71.4%) were in corticosteroid-free clinical remission and 41 of 51 (80.4%) were in biochemical remission. Median clinical and biochemical disease levels remained stable after the switch to subcutaneous treatment and weren’t significantly different, compared with baseline measurements.

Median vedolizumab serum concentrations increased from 19 mcg/mL at the time of the switch to 31 mcg/mL at 12 weeks after the switch and 37 mcg/mL at 24 weeks. Serum concentrations of less than 25 mcg/mL were associated with lower rates of corticosteroid-free clinical remission, and serum concentrations of greater than 40 mcg/mL were associated with higher biochemical remission rates.

Importantly, there was no association between vedolizumab serum concentrations and the risk of adverse events that were deemed probably related to subcutaneous injection or infections.

“The most important point to understand here is that SC VDZ can be used to maintain clinical remission after IV VDZ induction in a real-world setting,” said Brian DeBosch, MD, PhD, associate professor of cell biology and physiology at Washington University, St. Louis.

Dr. DeBosch, who wasn’t involved with this study, noted that previous data have indicated that switching from intravenous to subcutaneous treatment after a 6-week induction is superior to placebo in maintaining clinical and biochemical remission. However, studies haven’t quantified the optimal timing and therapeutic efficacy of switching.

“This is critical to quantify because SC VDZ has slower and lower peak bioavailability when compared with IV administration,” he said. “These data indicate that IV induction overcomes the known pharmacokinetic limitations of SC VDZ during the induction phase.”

However, there are still some limitations and areas for future research around switching administration, Dr. DeBosch noted.

“A key comparison lacking in the study is the mean and trough serum VDZ, and proportion of patients with relapsing disease in patients on continued IV VDZ,” he said. “Yet, these data nevertheless indicate that tandem IV-SC drug administration can maximize the induction and maintenance of remission in IBD, while also mitigating some of the barriers associated with long-term, continued IV VDZ administration.”

The study authors reported advisory fees and speaker fees from several pharmaceutical companies, and some authors have received funding or served on advisory boards for Takeda Pharmaceuticals, which manufactures vedolizumab. Dr. DeBosch reported no relevant disclosures.

Switching from intravenous to subcutaneous vedolizumab for maintenance treatment of inflammatory bowel diseases appears to be effective, according to a study providing real-world data.

Subcutaneous treatment could reduce direct health care costs because no infusion equipment is necessary, as well as societal costs because patients don’t need to take time off work or travel to infusion locations, wrote the researchers, led by Adriaan Volkers, MD, a doctoral candidate in gastroenterology and hepatology at the Amsterdam Gastroenterology Endocrinology Metabolism Research Institute at the University of Amsterdam in The Netherlands.

“The option of a SC formulation of VDZ [vedolizumab] offers patients a choice regarding the route of administration,” they wrote. The study was published in Alimentary Pharmacology and Therapeutics.

Dr. Volkers and colleagues assessed the effectiveness, safety, drug discontinuation, and pharmacokinetics of a switch from intravenous to subcutaneous maintenance vedolizumab in a prospective real-world cohort of patients from two separate studies in The Netherlands between July 2020 and November 2021.

The cohort comprised 135 adults who had greater than 4 months of IV vedolizumab: 82 patients with Crohn’s disease and 53 with ulcerative colitis. Prospective follow-up took place during scheduled outpatient clinic visits at weeks 12 and 24 after switching administration. Patients received 108 mg of subcutaneous vedolizumab once every 2 weeks.

Overall, 16 patients (11.9%) discontinued subcutaneous administration, including 11 patients (13.4%) with Crohn’s disease who stopped after a median of 18 weeks, as well as 5 patients (9.4%) with ulcerative colitis who stopped after a median of 6 weeks. Four patients, who all had Crohn’s disease, discontinued vedolizumab and switched to a different treatment because of loss of response. Nine patients switched back to IV administration because of adverse events, and three switched back because of fear of needles.

In total, there were 59 adverse events and 13 infections that were possibly or probably related to subcutaneous injection among 42 patients. The most common adverse events that were probably related were injection site reactions such as pain or swelling, reported among 15 patients, and headaches, reported among 6 patients.

At the initiation of therapy, 57 of 81 Crohn’s disease patients (70.4%) were in corticosteroid-free clinical remission and 53 of 80 (66.3%) were in biochemical remission, which was defined as C-reactive protein levels of 5 mg/L or less and fecal calprotectin levels of 250 mcg/g or less. For ulcerative colitis patients, 35 of 49 (71.4%) were in corticosteroid-free clinical remission and 41 of 51 (80.4%) were in biochemical remission. Median clinical and biochemical disease levels remained stable after the switch to subcutaneous treatment and weren’t significantly different, compared with baseline measurements.

Median vedolizumab serum concentrations increased from 19 mcg/mL at the time of the switch to 31 mcg/mL at 12 weeks after the switch and 37 mcg/mL at 24 weeks. Serum concentrations of less than 25 mcg/mL were associated with lower rates of corticosteroid-free clinical remission, and serum concentrations of greater than 40 mcg/mL were associated with higher biochemical remission rates.

Importantly, there was no association between vedolizumab serum concentrations and the risk of adverse events that were deemed probably related to subcutaneous injection or infections.

“The most important point to understand here is that SC VDZ can be used to maintain clinical remission after IV VDZ induction in a real-world setting,” said Brian DeBosch, MD, PhD, associate professor of cell biology and physiology at Washington University, St. Louis.

Dr. DeBosch, who wasn’t involved with this study, noted that previous data have indicated that switching from intravenous to subcutaneous treatment after a 6-week induction is superior to placebo in maintaining clinical and biochemical remission. However, studies haven’t quantified the optimal timing and therapeutic efficacy of switching.

“This is critical to quantify because SC VDZ has slower and lower peak bioavailability when compared with IV administration,” he said. “These data indicate that IV induction overcomes the known pharmacokinetic limitations of SC VDZ during the induction phase.”

However, there are still some limitations and areas for future research around switching administration, Dr. DeBosch noted.

“A key comparison lacking in the study is the mean and trough serum VDZ, and proportion of patients with relapsing disease in patients on continued IV VDZ,” he said. “Yet, these data nevertheless indicate that tandem IV-SC drug administration can maximize the induction and maintenance of remission in IBD, while also mitigating some of the barriers associated with long-term, continued IV VDZ administration.”

The study authors reported advisory fees and speaker fees from several pharmaceutical companies, and some authors have received funding or served on advisory boards for Takeda Pharmaceuticals, which manufactures vedolizumab. Dr. DeBosch reported no relevant disclosures.

Switching from intravenous to subcutaneous vedolizumab for maintenance treatment of inflammatory bowel diseases appears to be effective, according to a study providing real-world data.

Subcutaneous treatment could reduce direct health care costs because no infusion equipment is necessary, as well as societal costs because patients don’t need to take time off work or travel to infusion locations, wrote the researchers, led by Adriaan Volkers, MD, a doctoral candidate in gastroenterology and hepatology at the Amsterdam Gastroenterology Endocrinology Metabolism Research Institute at the University of Amsterdam in The Netherlands.

“The option of a SC formulation of VDZ [vedolizumab] offers patients a choice regarding the route of administration,” they wrote. The study was published in Alimentary Pharmacology and Therapeutics.

Dr. Volkers and colleagues assessed the effectiveness, safety, drug discontinuation, and pharmacokinetics of a switch from intravenous to subcutaneous maintenance vedolizumab in a prospective real-world cohort of patients from two separate studies in The Netherlands between July 2020 and November 2021.

The cohort comprised 135 adults who had greater than 4 months of IV vedolizumab: 82 patients with Crohn’s disease and 53 with ulcerative colitis. Prospective follow-up took place during scheduled outpatient clinic visits at weeks 12 and 24 after switching administration. Patients received 108 mg of subcutaneous vedolizumab once every 2 weeks.

Overall, 16 patients (11.9%) discontinued subcutaneous administration, including 11 patients (13.4%) with Crohn’s disease who stopped after a median of 18 weeks, as well as 5 patients (9.4%) with ulcerative colitis who stopped after a median of 6 weeks. Four patients, who all had Crohn’s disease, discontinued vedolizumab and switched to a different treatment because of loss of response. Nine patients switched back to IV administration because of adverse events, and three switched back because of fear of needles.

In total, there were 59 adverse events and 13 infections that were possibly or probably related to subcutaneous injection among 42 patients. The most common adverse events that were probably related were injection site reactions such as pain or swelling, reported among 15 patients, and headaches, reported among 6 patients.

At the initiation of therapy, 57 of 81 Crohn’s disease patients (70.4%) were in corticosteroid-free clinical remission and 53 of 80 (66.3%) were in biochemical remission, which was defined as C-reactive protein levels of 5 mg/L or less and fecal calprotectin levels of 250 mcg/g or less. For ulcerative colitis patients, 35 of 49 (71.4%) were in corticosteroid-free clinical remission and 41 of 51 (80.4%) were in biochemical remission. Median clinical and biochemical disease levels remained stable after the switch to subcutaneous treatment and weren’t significantly different, compared with baseline measurements.

Median vedolizumab serum concentrations increased from 19 mcg/mL at the time of the switch to 31 mcg/mL at 12 weeks after the switch and 37 mcg/mL at 24 weeks. Serum concentrations of less than 25 mcg/mL were associated with lower rates of corticosteroid-free clinical remission, and serum concentrations of greater than 40 mcg/mL were associated with higher biochemical remission rates.

Importantly, there was no association between vedolizumab serum concentrations and the risk of adverse events that were deemed probably related to subcutaneous injection or infections.

“The most important point to understand here is that SC VDZ can be used to maintain clinical remission after IV VDZ induction in a real-world setting,” said Brian DeBosch, MD, PhD, associate professor of cell biology and physiology at Washington University, St. Louis.

Dr. DeBosch, who wasn’t involved with this study, noted that previous data have indicated that switching from intravenous to subcutaneous treatment after a 6-week induction is superior to placebo in maintaining clinical and biochemical remission. However, studies haven’t quantified the optimal timing and therapeutic efficacy of switching.

“This is critical to quantify because SC VDZ has slower and lower peak bioavailability when compared with IV administration,” he said. “These data indicate that IV induction overcomes the known pharmacokinetic limitations of SC VDZ during the induction phase.”

However, there are still some limitations and areas for future research around switching administration, Dr. DeBosch noted.

“A key comparison lacking in the study is the mean and trough serum VDZ, and proportion of patients with relapsing disease in patients on continued IV VDZ,” he said. “Yet, these data nevertheless indicate that tandem IV-SC drug administration can maximize the induction and maintenance of remission in IBD, while also mitigating some of the barriers associated with long-term, continued IV VDZ administration.”

The study authors reported advisory fees and speaker fees from several pharmaceutical companies, and some authors have received funding or served on advisory boards for Takeda Pharmaceuticals, which manufactures vedolizumab. Dr. DeBosch reported no relevant disclosures.